NCT05666102

Brief Summary

The goal of this pilot study is to gather and analyze qualitative data from focus groups with Transgender men who have sex with men (TMSM) to learn more about the life experiences unique to TMSM that influence their attitudes and beliefs about HIV risk, as well as to better understand the intersections of these specific sexual and gender identities.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2022

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

November 21, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 27, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2023

Completed
Last Updated

November 9, 2023

Status Verified

November 1, 2023

Enrollment Period

3 months

First QC Date

November 21, 2022

Last Update Submit

November 7, 2023

Conditions

TransgenderismHIV Infections

Keywords

TransgenderLGBTQHIVQualitative

Outcome Measures

Primary Outcomes (1)

  • Post-hoc thematic analysis across five domains

    Post-focus group thematic analysis of attitudes and preferences of HIV prevention messaging and strategies for transgender men and transmasculine people in five separate domains: 1. Partner selection and sorting among trans men who have sex with cis men (TMSM); 2. TMSM's perceptions of HIV risk in their lived experiences; 3. Exploring the various types of sexual behavior TMSM are engaging in; 4. Understanding HIV prevention strategies currently used by TMSM; and 5. Examine the preferences TMSM have for receiving information related to sexual health and HIV prevention.

    up to 9 months

Study Arms (1)

Focus Groups

OTHER

Focus groups will occur during the course of the study period.

Behavioral: Transgender men's perspectives on HIV risk and HIV prevention interventions

Interventions

Transgender men's perspectives on HIV risk and HIV prevention interventionsBEHAVIORAL

Investigators will enroll 30 TMSM in 5 focus groups where they will examine the unique contexts in which risk for HIV acquisition occurs for TMSM, and explore participant preferences for HIV prevention services. Focus group questions will focus on five areas: 1) Gathering information related to partner selection and sorting among TMSM; 2) assessing TMSM's perceptions of HIV risk in their lived experiences; 3) exploring the various types of sexual behavior TMSM are engaging in; 4) understanding the various HIV prevention strategies currently being deployed by TMSM; and 5) examine the preferences TMSM have for receiving information related to sexual health and HIV prevention information.

Focus Groups

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsStudy is open to individuals assigned/designated female at birth (AFAB/DFAB) but who currently identify as a transgender man or transmasculine person.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • +; living in the United States;
  • Assigned female at birth;
  • Current gender identity of trans man or transmasculine;
  • Sexual orientation of NOT heterosexual;
  • Has access to the Internet.

You may not qualify if:

  • Under 18;
  • Living outside of the US;
  • Assigned male at birth;
  • Current gender identity OUTSIDE of transgender man or transmasculine person;
  • Heterosexual/straight;
  • Does not have access to the Internet.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute for Sexual and Gender Minority Health and Wellbeing

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

TranssexualismHIV Infections

Condition Hierarchy (Ancestors)

SexualitySexual BehaviorBehaviorBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant Professor

Study Record Dates

First Submitted

November 21, 2022

First Posted

December 27, 2022

Study Start

November 1, 2022

Primary Completion

January 30, 2023

Study Completion

August 30, 2023

Last Updated

November 9, 2023

Record last verified: 2023-11

Locations

US(1)